1. ISO 9001:2015 Revision Explaining the Key Changes
08/12/2015

2. Agenda A changing world - background to the revision
10/11/2018
Agenda
A changing world - background to the revision
Why ISO 9001 is important
What are the key changes
What are the benefits
What we need to do
Our project team
Next steps
ISO 9001 Quality Management Systems is being revised and is expected to be published in September 2015.
The 2015 version will be a major revision of the standard and incorporates some new elements, enhancies some existing requirements and deletes some previous requirements.
This presentation covers the background to the revision, top level changes and what this means for our organization.
08/12/2015

3. 10/11/2018
A changing world since 2000
1) Increasing market competitiveness and price sensitivity
nationally
internationally
2) Recession led restructuring
complex
leaner with less resources
cost conscious
3) Better understanding of risk prevention
4) Greater focus on corporate reputation and governance
A lot has changed since the last major revision to ISO Here’s our view of 4 major trends that we’ve seen shape the business landscape:
First, businesses are facing increasing pressure from  a much more competitive market around the globe, and also from overseas players. Geographical boundaries are almost insignificant in today’s global economy, meaning you’re not just competing with your neighbours
Second, For those organizations that survived the recession, most have implemented cost saving measures and many have faced complex restructures, more often than not leaving much leaner teams in place.  Businesses are more cost conscious than ever and demand more joined-up and efficient processes that eliminate duplication of effort
Organizations, not just the large corporates, but also SMEs are more risk conscious than ever. The rising focus on risk registers and scenario planning means organizations aren’t just thinking about running their business today, they’re planning for the future.
And finally, in this increasingly competitive environment and with a number of high profile PR disasters, we are seeing a greater focus on organizations protecting and enhancing their corporate reputation.
But one thing has remained constant, to be successful businesses have to adapt to meet the growing needs of customers. ISO 9001 was originally written with the customer in mind and that remains the priority for ISO 9001:2015.
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4. Background to the revision
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Background to the revision
All standards are reviewed regularly to ensure they:
Adapt to a changing world
Place greater focus on the customer and enhanced customer satisfaction
Reflect increasingly complex organizational environments
Address the needs of all relevant parties/stakeholders
Major changes include:
A foundation for the integration with other management systems
An introduction to risk-based thinking
Aligning QMS policies and objectives with organizational strategy
Greater flexibility with documentation
ISO 9001 was last published in 2008 although the last major change was in The world has changed significantly since then and the ISO committee felt it was important to revise the standard to ensure that reflected that changing world and increasingly complex business environment,
The standard has been written under the new high level structure (HLS) mandated by the ISO management board which provides a framework with identical structure, core text and common terms and definitions
As well as being written under the new structure, some previous requirements have been deleted and new requirements have been inserted.
Customers remain the primary focus
08/12/2015

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Why ISO 9001 is important
ISO 9001 has helped millions of organizations throughout the world to
Improve products and services
Inspires trust in our business
Reduce the likelihood of mistakes
Attract new customer
Access tender list
Increase competitiveness
08/12/2015

6. Context of Organization
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ISO 9001 – Key changes
There is a greater emphasis for senior managers to be involved in the strategic alignment of the management system
Leadership
An effective risk management process will be critical for successful certification to the new version
Risk
Relevant needs of interested parties are a new focus
Context of Organization
The standard has been written in accordance with the new high level structure with a more holistic approach
Annex SL
ISO 9001 has been written using a new high level structure (Annex SL) common to all management system standards which provides common language and numbering and core definitions

7. ISO 9001 Key differences ISO 9001:2008 ISO DIS 9001:2014
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system
4 Context of the organization
New requirement
5 Management responsibility
5 Leadership
Enhanced requirements
6 Resource management
6 Planning
Significant change
7 Product realization
7 Support
Enhanced requirement
8 Measurement, analysis and improvement
8 Operation
Simplified requirement
9 Performance evaluation
10 Improvement
More structured approach

8. Benefits Bringing Quality into the heart of our business
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Benefits
Bringing Quality into the heart of our business
Quality management will be integrated and aligned with our business strategies which will improve performance and drive real value
Introduction of Risk & Opportunity Management
Will help identify and manage risk more effectively and opportunities that contribute to bottom line improvements
An Integrated Approach
It will be easier to implement more than one management system providing a more holistic view leading to cost savings
Leadership
Greater involvement by our leadership team will ensure that we’ll all be motivated towards the organizations goals and objectives

9. What we need to do Set up a project team to manage the changes
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What we need to do
Set up a project team to manage the changes
Communicate the project across the whole organization
Create an implementation plan and monitor progress
Take a fresh look at our QMS
Highlight the changes as opportunities for improvement
Make changes to our documentation to reflect the new structure (as necessary)
Implement the new requirements on leadership, risk and context of the organization
Review the effectiveness of our current control set
Carry out an impact assessment
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Our Project Team
Insert Names
08/12/2015

11. Next Steps/Timescales
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Next Steps/Timescales
Insert timescales…
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